Investigation - evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for the complaint device found no relevant non-conformances for the device lot or sub-assemblies.A review of similar device lots sent out on the same day revealed no relevant non-conformances.It should be noted there are no other reported complaints from the complaint device lot or the similar device lots that left production the same day.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.Based on the information provided, no returned product, and the results of our investigation, a definitive root cause could not be established.Appropriate measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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